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NICE recommends Novartis' ribociclib in combination with fulvestrant for breast cancer

Published on 26/02/21 at 10:53am

NICE has recommended Novartis’ Kisqali (ribociclib) in combination with fulvestrant for women with prior endocrine therapy.

It will be made available for routine use on the NHS for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy.

NICE said in a statement that thousands of breast cancer patients will now benefit from routine access to the newly approved drug combination.

In the UK, around 55,000 women are diagnosed with breast cancer each year, and 30% of women with earlier stages of breast cancer will develop advanced disease. Eighty-five percent of women diagnosed with advanced breast cancer will not live longer than five years.

The recommendation from NICE is based on the latest data from the second line subpopulation of the MONALEESA-3 clinical study, where ribociclib plus fulvestrant demonstrated a median progression-free survival (PFS) of 14.6 months compared with 9.1 months with placebo plus fulvestrant.

MONALEESA-3 is the largest trial to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women. The study included women with no prior endocrine therapy, including those diagnosed de novo, women who relapsed within 12 months of adjuvant therapy, and women who progressed on endocrine therapy for advanced disease.

Dr Duncan Wheatley, Royal Cornwall Hospital NHS Trust, commented: “This positive decision by NICE to provide routine commissioning of Kisqali,in combination with fulvestrant in the second line setting as a standard of care on the NHS marks good news for those living with secondary breast cancer in the UK.

“Based on the pivotal results from the MONALEESA-3 study, the approval is an important move towards ensuring people living with this incurable condition have access to treatments where their disease can be controlled and their quality of life is supported.”

Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland, also said: “The recommendation by NICE is a welcome development for people living with advanced breast cancer who require additional treatment options that can maintain their quality of life and provide them with more time without disease progression.

“Today’s NICE recommendation further demonstrates the value of Kisqali treatment for advanced breast cancer patients. In securing the routine NHS funding for Kisqali in combination with fulvestrant, we can help shift some of the uncertainty that patients may have been experiencing while ribociclib was only available through the Cancer Drugs Fund.”

Darcy Jimenez

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